Feds Suspect Novartis of Shady Marketing of Gilenya MS Pill – Exclusion a Possibility
Latest FDA and cGMP Compliance News The word is that the marketing arm of Novartis is being carefully probed by the US Attorney in New York. That office issued a demand for a civil investigation this week for documents and information regarding marketing for its multiple sclerosis treatment Gilenya. The feds also want to find […]
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J&J Pays $23 Million to End Recall Lawsuit
Latest FDA and cGMP Compliance News Johnson & Johnson has reached a settlement to pay $23 million to finish off a lawsuit from investors who say that the firm was concealing failures in quality control that resulted in a sweeping recall of medicines for children, which led to safety concerns for some users of the […]
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FDA Sends Warning Letter to Genentech Trial Investigator
Latest FDA and cGMP Compliance News A clinical investigator for a phase III clinical trial for a Genentech drug got a warning letter from the agency for not following protocol and keeping proper case histories of patients. The drug in question was Lucentis, and it is for macular degeneration. FDA stated in the warning letter […]
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Past Expertbriefings.com Webinars Available for Download
Each of these can be downloaded the same day. Each is 1/2 price, or $199. Interested? Contact us! 2013 Top Compliance Trends for 483s and Warning Letters – Dennis Moore, AUK Technical Services 2012 Warning Letter Update, Sheldon Bradshaw, Former FDA Chief Counsel 2012 Increased Use of Consent Decrees, Sheldon Bradshaw, Former FDA Chief Counsel […]
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Fraud Charge on Danish Doc for Payments from Drugmakers
Latest FDA and cGMP Compliance News In Norway, there is a cardiologist for a large hospital that has been charged with fraud for going on fishing trips and buying furniture with money he was given from Pfizer and Merck. The word is that the companies made payments to him for clinical study work that was […]
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GSK Now the Leader in Chinese Bribery Scandal
Latest FDA and cGMP Compliance News Another day has come and we are reading about more very damaging details about the bribery scandal that is engulfing GlaxoSmithKline in China. Authorities there have provided the media with the names of several of the senior executives that were arrested. All of them are nationals of China and […]
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Fake Avastin Salesman Ducks Jail Time
Latest FDA and cGMP Compliance News We saw a lot of ruckus about the fake Avastin scandal last year, but last week, federal prosecutors were not able to get a one year prison term for an ex-salesman at a pharmacy in Canada that had pleaded guilty for a felony because he sold misbranded drugs […]
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Lawyer Fights With FDA on J&J Risperdal Court Papers
Latest FDA and cGMP Compliance News A lawyer is pushing FDA to try to obtain documents that supposedly show unpleasant side effects of the antipsychotic drug Risperdal. But the documents cannot be released to the public because of a court order. The papers were sealed by a judge in Pennsylvania in a case involving […]
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China Arrests Dozens of Glaxo Employees in Epic Scandal
Latest FDA and cGMP Compliance News The very serious tax evasion and bribery scandal that has engulfed GlaxoSmithKline in China has resulted in the arrest of more than 30 employees. Among that number is at least six executives who are being confined to their homes. One of them is the legal counsel for GSK and […]
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Hikma Hit With FDA Warning Letter, West Ward Plant Closes But Reopens
Latest FDA and cGMP Compliance News The pharmaceutical company Hikma has been battling serious cGMP problems at its West Ward Pharmaceutical facility in Eatontown NJ, and Hikma did need to close down the plant earlier this year due to the problems, but it has since reopened. Hikma noted in its recent quarterly report that FDA […]
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